Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Thus, ideally treatment at this stage would improve both cognitive symptoms and some of the other problems associated with these symptoms.

Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease patients little is known about how best to treat it. This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to moderate dementia in Alzheimer and Parkinson's disease patients.

The 8-item version of the PDQ-39 will serve as a disease-specific measure of health-related Quality of Life.)

Gordon Diagnostic System (GDS) [ Time Frame: The GDS will be administered at baseline, week 10, week 14, and week 24. ] [ Designated as safety issue: No ]

Attentional impairment specifically is a strong predictor of the ability to perform Activities of Daily Living in Parkinson's Disease. Therefore, we will add the GDS as a specific measure of attention.

The DRS-2 has been validated as an assessment instrument for Parkinson's Disease Dementia, discriminates between Parkinson's Disease-Mild Cognitive Impairment and Parkinson's Disease Dementia, predicts long-term conversion to Parkinson's Disease Dementia, and is sensitive to improvements in cognition and Activities of Daily Living function associated with treatment.

The 15-item Geriatric Depression Scale (GDS-15), State Anxiety Inventory (SAI), Apathy Scale, and a modified Parkinson's Psychosis Rating Scale (PPRS) will be used as measures of severity of psychiatric symptoms and to probe the impact of rivastigmine treatment on psychiatric symptoms that are frequently co-morbid with cognitive impairment in Parkinson's Disease.

Measures of Parkinson's Disease Severity [ Time Frame: The UPDRS will be administered at baseline, week 10, week 14, and week 24, and the Hoehn & Yahr stage and Schwab and England Scale will be administered at baseline only ] [ Designated as safety issue: No ]

The UPDRS motor component (Part III) and the Hoehn & Yahr stage will be used as measures of disease severity. The Schwab and England will be used as a measure of Activities of Daily Living.

Everyday Cognition Battery (ECB) and Memory Acquisition-Transfer Task [ Time Frame: If time allows both measures will be administered at baseline, week 10, week 14, and week 24. ] [ Designated as safety issue: No ]

The Everyday Cognition Battery will be administered as a performance-based measure of functional abilities. Likewise, the Memory Acquisition-Transfer Task, a computer-based measure of memory acquisition and transfer will be administered if time allows.

The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).

Active Comparator: Exelon Patch (rivastigmine transdermal system)

Drug: Exelon Patch (rivastigmine transdermal system)

The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.

5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )

Detailed Description:

This study has 2 phases. Each phase will last 10 weeks and there will be a 4-week break between the 2 phases. Thus, you will be enrolled in the study for a total of 24 weeks. Over the course of the 24-week period we will schedule to see you in-person 6 times and check-in with you on the telephone 4 times, 2 times during each phase.

Phase I

Screening (may be the same day as the baseline visit) - Research personnel will determine if you are eligible to participate in this study.

Visit 1 - Baseline Visit, Start Study Medication

Phone Call 1 - Check in to see how you are feeling after starting the study medication

Visits 1, 3, 4, and 6 will last for about 2 ½ hours and visits 2 and 5 about 30 minutes. The 'check in' phone calls will last approximately 5-10 minutes.

After 24 weeks, your study participation will be over.

Eligibility

Ages Eligible for Study:

40 Years to 85 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Participants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel.

Participants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable).

Participants are capable of giving informed consent supported by not meeting Parkinson's disease Dementia criteria; this will be determined by study personnel.

Exclusion Criteria:

Active suicide ideation.

Weighing less than 100 lbs (45 kgs).

History of Deep Brain Stimulation surgery.

Diagnosis of Dementia

Taking certain types of medications may be an exclusion criteria, this will be reviewed with all potential participants.

Females that are pregnant, planning to become pregnant, or are breastfeeding will not be included in the study. Females of childbearing potential will need to verify that they are not pregnant by a negative urine pregnancy test.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519271